syngo Application Software
Siemens Medical Solutions USA, IncThe syngo Application Software is a medical imaging software developed by Siemens that enables real-time viewing, manipulation, 3D visualization, communication, and postprocessing of medical images. It supports diagnostic review and image-guided interventional procedures across multiple imaging modalities and clinical applications, improving workflow and aiding clinicians in diagnosis and treatment planning.
Intended Use
Medical software for real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data on exchange media, used for diagnostic image viewing and postprocessing, including during interventional procedures.
Technology
Software operates on stand-alone diagnostic workstations or integrated with Siemens angiography systems. Supports image-guided surgery, image fusion, navigation systems, and modular Windows-based software options. Includes features for minimally invasive procedures and tumor treatment. Updated software version VE40C with new 'myNeedle Guide' and 'Biplane 3D Roadmap' functionalities.
Performance
Non-clinical performance testing includes software verification and validation per FDA software guidance documents. Bench tests and human factor usability testing showed no safety issues. Cybersecurity measures conform to IEC 80001-1:2010. Test results were acceptable with no new safety or effectiveness concerns. Updated software features underwent functional performance testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2024
4 months - 2
FDA Approval
10/11/2024
Other devices from Siemens Medical Solutions USA, Inc
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.